Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
4 300.36 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
430 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
857.5 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.67 mg/kg food
Assessment factor:
300

Additional information

Study reports have been available for acute tests with fish, invertebrates and algae. Long-term aquatic toxicity tests were waived. The results are summarized as below:

The fish acute toxicity test was performed according to OECD guideline No. 203 under GLP compliance. The result showed the test substance induced no visible or lethal effects in carp at 0.020 mg/l, being the average measured exposure concentration in a WAF prepared at a loading rate of 100 mg/l (NOEC). The 96 h-LC50 exceeded 0.020 mg/l, being the average measured exposure concentration in a WAF prepared at a loading rate of 100 mg/l.

The acute toxicity test with Daphnia magna was performed according to OECD guideline No. 202 under GLP compliance. The result showed the test substance did not induce acute immobilisation of Daphnia magna at 0.62 mg/l, being the average measured concentration in a WAF prepared at a loading rate of 100 mg/l after 48 hours of exposure (NOEC). The 48 h-EC50 exceeded 0.62 mg/l, being the average measured concentration in a WAF prepared at a loading rate of 100 mg/l.

Algal growth inhibition test was performed according to OECD guideline No. 201 under GLP compliance. The result showed no reduction of growth rate or inhibition of yield was recorded at any of the WAFs of Alkylated Naphthalene tested. Both the EC50 for growth rate reduction (72 h-ERC50) and the EC50 for yield inhibition (72 h-EYC50) exceeded 0.2 mg/l, being the Time Weight Average concentration in a WAF prepared at a loading rate of 100 mg/l.

Due to the poor water solubility of test substance (below 3.75 μg/L), the exposure to the aquatic compartment is negligible. In addition, it is sufficient for the classification and PBT/vPvB assessment based on available information. Thus, no further long-term aquatic toxicity tests will be necessary.

Based on the acute toxicity tests results of three trophic levels (fish, Daphnia and algae), the short-term L/EC50 values are all above 100 mg/l, thus the loading rate of 100 mg/l is used as the key value for PNECwater calculation.

Due to lack of aquatic toxicity no hazard for the aquatic compartment is expected but nevertheless a PNEC was derived as input for sediment and soil PNEC calculation based on the partitioning method.

Although no bioaccumulation is expected through the food chain, a PNEC oral was derived, based on the result of the OECD422 study with rats.

Conclusion on classification

The substance does not meet the criteria for classification as given in Commission Regulation (EU) No 286/2011 amending for the second time Regulation (EC) No 1272/2008. The substance is not classified for environmental hazards on the basis of the available information on ecotoxicology, environmental fate and physical-chemical properties. However, as the threshold for classification with R53 according to DSD (Directive 67/548/EEC) regarding bioaccumulation is a BCF of 100 rather than 500 as in CLP (the BCF for this substance was estimated being 309 according to a valid QSAR model), the substance requires classification according to DSD with R53.